Reported Mar 10, 2021 · Ongoing
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN:…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN
8 of 8 products
| # | Product as published |
|---|---|
| 1 | M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300 |
| 2 | M00562321 (Box 10), M00562320 |
| 3 | M00562341 (Box 10), M00562340 |
| 4 | M00562451 (Box 10), M00562450 |
| 5 | M00562401 (Box 10), M00562400 |
| 6 | M00562402 (Box 40), M00562400 |
| 7 | M00562422 (Box 40), M00562420 |
| 8 | M00562471 (Box 10), M00562470. |
- Lot codes and dates
- Outer box GTIN08714729019251
- Inner pouch GTIN
08714729747680 Lot/Batch#: 2472531924782695
- Outer box GTIN08714729019312
- Inner pouch GTIN
08714729747833 Lot/Batch#: 2484259724812577
- Outer box GTIN08714729019336
- Inner pouch GTIN
08714729747857 Lot/Batch#: 24889757247192022470953624773287
- Outer box GTIN08714729019350
- Inner pouch GTIN
08714729747871 Lot/Batch#: 24782693247329642488975524780939
- Outer box GTIN08714729071068
- Inner pouch GTIN
08714729747970 Lot/Batch#: 24882357247826892478268724729758
- Outer box GTIN08714729019411
- Inner pouch GTIN08714729747932 Lot/Batch#: 24961643
- Outer box GTIN08714729501640
- Inner pouch GTIN
08714729747932 Lot/Batch#: 249616452498926024844193
- Outer box GTIN08714729501657
- Inner pouch GTIN08714729747956 Lot/Batch#: 25010054
- Outer box GTIN08714729019459
- Inner pouch GTIN08714729747994 Lot/Batch#: 25016793
- Amount recalled
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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